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En studie av Talquetamab hos deltagare med återfall eller refraktärt multipelt myelom (MonumenTAL-1)

2 november 2026 uppdaterad av: Janssen Research & Development, LLC

En fas 1/2, först i människa, öppen dosupptrappningsstudie av Talquetamab, en humaniserad GPRC5D x CD3 bispecifik antikropp, hos patienter med återfall eller refraktärt multipelt myelom

The purpose of this study is to evaluate the efficacy and safety of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

510

Fas

  • Fas 2

Utökad åtkomst

Godkänd till försäljning till allmänheten. Se utökad åtkomstpost.

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Belgien
      • Edegem, Belgien, 2650
        • Avslutad
        • UZ Antwerpen
      • Leuven, Belgien, 3000
        • Aktiv, inte rekryterande
        • UZ Leuven
      • Liège, Belgien, 4000
        • Aktiv, inte rekryterande
        • CHU de Liège - Domaine Universitaire du Sart Tilman
      • Woluwe-Saint-Lambert, Belgien, 1200
        • Avslutad
        • UCL - Saint Luc
  • Frankrike
      • Créteil, Frankrike, 94000
        • Aktiv, inte rekryterande
        • CHU Henri Mondor
      • Lyon, Frankrike, 69002
        • Aktiv, inte rekryterande
        • Hospices Civils de Lyon HCL
      • Montpellier, Frankrike, 34295
        • Aktiv, inte rekryterande
        • CHU de Montpellier Hopital Saint Eloi
      • Nantes, Frankrike, 44093
        • Aktiv, inte rekryterande
        • C.H.U. Hotel Dieu - France
      • Pessac, Frankrike, 33604
        • Aktiv, inte rekryterande
        • CHU de Bordeaux - Hospital Haut-Leveque
      • Toulouse, Frankrike, 31059
        • Aktiv, inte rekryterande
        • Pôle IUC Oncopole CHU
  • Förenta staterna
    • Alabama
      • Birmingham, Alabama, Förenta staterna, 35294
        • Rekrytering
        • University of Alabama Birmingham
    • Arkansas
      • Little Rock, Arkansas, Förenta staterna, 72205
        • Rekrytering
        • University of Arkansas for Medical Sciences
    • California
      • Duarte, California, Förenta staterna, 91010
        • Avslutad
        • City of Hope
    • Florida
      • Hollywood, Florida, Förenta staterna, 33021
        • Rekrytering
        • Memorial Healthcare System
    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30322
        • Rekrytering
        • Emory University Winship Cancer Institute
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60637
        • Avslutad
        • University of Chicago
    • Kentucky
      • Louisville, Kentucky, Förenta staterna, 40207
        • Rekrytering
        • Norton Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, Förenta staterna, 48109
        • Rekrytering
        • University of Michigan Health System
    • Missouri
      • St Louis, Missouri, Förenta staterna, 63110
        • Rekrytering
        • Washington University School Of Medicine
    • New York
      • New York, New York, Förenta staterna, 10023
        • Rekrytering
        • Mount Sinai Medical Center
      • New York, New York, Förenta staterna, 10016
        • Aktiv, inte rekryterande
        • NYU Langone Health
      • Rochester, New York, Förenta staterna, 14642
        • Rekrytering
        • University of Rochester Medical Center
    • Oregon
      • Portland, Oregon, Förenta staterna, 97213
        • Avslutad
        • Providence Portland Medical Center
    • Tennessee
      • Nashville, Tennessee, Förenta staterna, 37203
        • Avslutad
        • Tennessee Oncology
  • Israel
      • Haifa, Israel, 31096
        • Aktiv, inte rekryterande
        • Rambam Medical Center
      • Haifa, Israel, 3436212
        • Aktiv, inte rekryterande
        • Carmel Medical Center
      • Jerusalem, Israel, 91120
        • Aktiv, inte rekryterande
        • Hadassah Medical Center
      • Ramat Gan, Israel, 52621
        • Aktiv, inte rekryterande
        • Sheba Medical Center
      • Tel Aviv, Israel, 64239
        • Aktiv, inte rekryterande
        • Tel Aviv Sourasky Medical Center
  • Japan
      • Chiba, Japan, 296-8602
        • Avslutad
        • Kameda Medical Center
      • Fukuoka, Japan, 814-0180
        • Avslutad
        • Fukuoka University Hospital
      • Gifu, Japan, 503-8502
        • Avslutad
        • Ogaki Municipal Hospital
      • Hokkaido, Japan, 006-8555
        • Avslutad
        • Teine Keijinkai Hospital
      • Kobe, Japan, 650 0047
        • Avslutad
        • Kobe City Medical Center General Hospital
      • Koshigaya, Japan, 343-8555
        • Avslutad
        • Dokkyo Medical University Saitama Medical Center
      • Kumamoto, Japan, 860-8556
        • Avslutad
        • Kumamoto University Hospital
      • Kurashiki, Japan, 710-8602
        • Avslutad
        • Kurashiki Central Hospital
      • Matsumoto, Japan, 399-8701
        • Avslutad
        • National Hospital Organization Matsumoto Medical Center
      • Okayama, Japan, 701-1192
        • Avslutad
        • National Hospital Organization Okayama Medical Center
      • Osaka, Japan, 543 8555
        • Avslutad
        • Japanese Red Cross Osaka Hospital
      • Shiwa-gun, Japan, 028-3695
        • Avslutad
        • Iwate Medical University Hospital
      • Ōtake, Japan, 739-0696
        • Aktiv, inte rekryterande
        • National Hospital Organization Hiroshima-Nishi Medical Center
  • Kina
      • Beijing, Kina, 100191
        • Avslutad
        • Peking University Third Hospital
      • Guangzhou, Kina, 510060
        • Aktiv, inte rekryterande
        • Sun Yat Sen University Cancer Center
      • Hangzhou, Kina, 310003
        • Aktiv, inte rekryterande
        • The 1St Affiliated Hospital of Medical College Zhejiang University
      • Hangzhou, Kina, 310003
        • Aktiv, inte rekryterande
        • The 1st Affiliated Hospital Of Medical College Zhejiang University 1
      • Suzhou, Kina, 215006
        • Aktiv, inte rekryterande
        • First Affiliated Hospital SooChow University
      • Tianjin, Kina, 300320
        • Aktiv, inte rekryterande
        • Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
      • Xi'an, Kina, 710004
        • Avslutad
        • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Xi'an, Kina, 710063
        • Avslutad
        • The First Affiliated Hospital of Xian Jiaotong University
  • Nederländerna
      • Amsterdam, Nederländerna, 1081 HV
        • Avslutad
        • VU Medisch Centrum
      • Utrecht, Nederländerna, 3584 CX
        • Avslutad
        • UMCU
  • Polen
      • Gdansk, Polen, 80 214
        • Aktiv, inte rekryterande
        • Uniwersyteckie Centrum Kliniczne
      • Gliwice, Polen, 44102
        • Avslutad
        • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
      • Poznan, Polen, 60-569
        • Aktiv, inte rekryterande
        • Uniwersytecki Szpital Kliniczny w Poznaniu
      • Warsaw, Polen, 02-781
        • Avslutad
        • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
      • Wroclaw, Polen, 50 367
        • Aktiv, inte rekryterande
        • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
  • Spanien
      • Badalona, Spanien, 08916
        • Avslutad
        • Hosp. Univ. Germans Trias I Pujol
      • Barcelona, Spanien, 8908
        • Aktiv, inte rekryterande
        • Inst. Cat. Doncologia-H Duran I Reynals
      • Barcelona, Spanien, 08035
        • Rekrytering
        • Hosp Univ Vall D Hebron
      • Madrid, Spanien, 28041
        • Avslutad
        • Hosp. Univ. 12 de Octubre
      • Madrid, Spanien, 28040
        • Avslutad
        • Hosp Univ Fund Jimenez Diaz
      • Murcia, Spanien, 30120
        • Aktiv, inte rekryterande
        • Hosp. Univ. Virgen de La Arrixaca
      • Pamplona, Spanien, 31008
        • Rekrytering
        • Clinica Univ. de Navarra
      • Pozuelo de Alarcón, Spanien, 28223
        • Avslutad
        • Hosp. Quiron Madrid Pozuelo
      • Salamanca, Spanien, 37007
        • Rekrytering
        • Hosp Clinico Univ de Salamanca
      • Santander, Spanien, 39008
        • Rekrytering
        • Hosp. Univ. Marques de Valdecilla
      • Seville, Spanien, 41013
        • Rekrytering
        • Hosp. Virgen Del Rocio
  • Sydkorea
      • Jeollanam-do, Sydkorea, 58128
        • Avslutad
        • Chonnam National University Hwasun Hospital
      • Seoul, Sydkorea, 06351
        • Avslutad
        • Samsung Medical Center
      • Seoul, Sydkorea, 05505
        • Avslutad
        • Asan Medical Center
      • Seoul, Sydkorea, 03080
        • Avslutad
        • Seoul National University Hospital
      • Seoul, Sydkorea, 03722
        • Avslutad
        • Severance Hospital Yonsei University Health System
      • Seoul, Sydkorea, 06591
        • Avslutad
        • The Catholic University of Korea Seoul St Marys Hospital
  • Tyskland
      • Berlin, Tyskland, 12203
        • Aktiv, inte rekryterande
        • Charite Campus Benjamin Franklin
      • Heidelberg, Tyskland, 69120
        • Aktiv, inte rekryterande
        • Universitaetsklinikum Heidelberg
      • Münster, Tyskland, 48149
        • Avslutad
        • Universitaetsklinikum Muenster
      • Würzburg, Tyskland, 97080
        • Aktiv, inte rekryterande
        • Universitatsklinikum Wurzburg

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria
  • Part 3: Measurable disease cohort A, cohort B, cohort C and cohort D: multiple myeloma must be measurable by central laboratory assessment; Cohort E: Multiple myeloma must be measurable by local laboratory assessment
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
  • Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (beta human chorionic gonadotropin [hCG]) or urine
  • Willing and able to adhere to the prohibitions and restrictions specified in this protocol

Exclusion Criteria:

  • Part 3 only: Cohort A and Cohort C only: exposed to a CAR-T or T cell redirection therapy at any time. Cohort B, Cohort D and Cohort E: T cell redirection therapy within 3 months
  • Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
  • Received a cumulative dose of corticosteroids equivalent to >= 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
  • Stroke or seizure within 6 months prior to signing the informed consent form (ICF)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Part 3: Cohort A (Talquetamab)

Cohort A will enroll participants with multiple myeloma who have previously received greater than or equal to (>=) 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (SC) at a recommended Phase 2 dose (RP2D) selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to open-label extension (OLE) phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the long-term extension (LTE) and will continue to receive study treatment.
Läkemedel: Talquetamab

Talquetamab will be administered SC until disease progression.

Andra namn:
  • JNJ-64407564
Experimentell: Part 3: Cohort B (Talquetamab)

Cohort B will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy and have been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (SC) at a recommended Phase 2 dose (RP2D) selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment.
Läkemedel: Talquetamab

Talquetamab will be administered SC until disease progression.

Andra namn:
  • JNJ-64407564
Experimentell: Part 3: Cohort C (Talquetamab)

Cohort C will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment.
Läkemedel: Talquetamab

Talquetamab will be administered SC until disease progression.

Andra namn:
  • JNJ-64407564
Experimentell: Part 3: Cohort D (Talquetamab)

Cohort D will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. Participants in this cohort will receive tocilizumab prophylaxis for cytokine release syndrome (CRS) including all outpatient dosing. Participants will transition to OLE upon communication by the sponsor. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment.
Läkemedel: Talquetamab

Talquetamab will be administered SC until disease progression.

Andra namn:
  • JNJ-64407564
Experimentell: Part 3: Cohort E (Talquetamab)

Cohort E will enroll participants with multiple myeloma who have previously received at least 1 proteasome inhibitor (PI), 1 immunomodulatory imide drug (IMiD), and 1 anti-cluster of differentiation 38 (CD38) monoclonal antibody.

Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. Participants will receive tocilizumab prophylaxis for CRS with consolidated priming dose schedules as well as possible transition to outpatient priming dosing transition to OLE upon communication by the sponsor. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment.
Läkemedel: Talquetamab

Talquetamab will be administered SC until disease progression.

Andra namn:
  • JNJ-64407564

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Response Rate (ORR)
Tidsram: Up to 2 years and 10 months

ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria.
Up to 2 years and 10 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Duration of Response (DOR)
Tidsram: Up to 2 years and 10 months

DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG criteria, or death due to PD, whichever occurs first.
Up to 2 years and 10 months
Very Good Partial Response (VGPR) or Better Rate
Tidsram: Up to 2 years and 10 months

VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria.
Up to 2 years and 10 months
Complete Response (CR) or Better Rate
Tidsram: Up to 2 years and 10 months

CR or better rate is defined as the percentage of patients who achieve CR or better according to IMWG response criteria.
Up to 2 years and 10 months
Stringent Complete Response (sCR) Rate
Tidsram: Up to 2 years and 10 months

sCR rate is defined as the percentage of patients who achieve sCR according to IMWG response criteria.
Up to 2 years and 10 months
Time to Response (TTR)
Tidsram: Up to 2 years and 10 months

TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better.
Up to 2 years and 10 months
Progression-Free Survival (PFS)
Tidsram: Up to 2 years and 10 months

PFS is defined as time from date of first dose of study drug to date of first documented PD, per IMWG criteria, or death due to any cause, whichever occurs first.
Up to 2 years and 10 months
Overall Survival (OS)
Tidsram: Up to 2 years and 10 months

OS is defined as the time from the date of first dose of study drug to the date of the participant's death.
Up to 2 years and 10 months
Minimal Residual Disease (MRD) Negative Rate
Tidsram: Up to 2 years and 10 months

MRD negativity rate is measured only for participants who achieve at least a CR but is reported based on all treated similar to the other response data.
Up to 2 years and 10 months
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Tidsram: Up to 2 years and 10 months

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Up to 2 years and 10 months
Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
Tidsram: Up to 2 years and 10 months

An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Up to 2 years and 10 months
Number of Participants with AEs by Severity
Tidsram: Up to 2 years and 10 months

Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.
Up to 2 years and 10 months
Number of Participants with Abnormalities in Clinical Laboratory Values
Tidsram: Up to 2 years and 10 months

Number of participants with abnormalities in clinical laboratory values (such as hematology, serum chemistry and coagulation) will be reported.
Up to 2 years and 10 months
Serum Concentration of Talquetamab
Tidsram: Up to 2 years and 10 months

Serum samples will be analyzed to determine concentrations of talquetamab.
Up to 2 years and 10 months
Number of Participants with Talquetamab Antibodies
Tidsram: Up to 2 years and 10 months

Antibodies to talquetamab will be assessed to evaluate potential immunogenicity.
Up to 2 years and 10 months
Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30)
Tidsram: Baseline up to 2 years and 10 months

The EORTC- QLQ-Core-30 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The recall period is 1 week ("past week") and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.
Baseline up to 2 years and 10 months
Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L)
Tidsram: Baseline up to 2 years and 10 months

The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores for the 5 separate questions are categorical and cannot be analyzed as cardinal numbers.
Baseline up to 2 years and 10 months
Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS)
Tidsram: Baseline up to 2 years and 10 months

The PGIS is a single item that assesses severity of the participant's health state, on a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe).
Baseline up to 2 years and 10 months
Overall Response Rate (ORR) in Participants with High-risk Molecular Features
Tidsram: Up to 2 years and 10 months

ORR in participants with high risk is defined as the overall response rate among the high risk molecular subgroups or other high-risk molecular subtypes.
Up to 2 years and 10 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Janssen Research & Development, LLC

Utredare

  • Studierektor: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 februari 2021

Primärt slutförande (Beräknad)

30 juni 2027

Avslutad studie (Beräknad)

30 mars 2029

Studieregistreringsdatum

Först inskickad

16 november 2020

Först inskickad som uppfyllde QC-kriterierna

16 november 2020

Första postat (Faktisk)

18 november 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CR108920
  • 2017-002400-26 (EudraCT-nummer)
  • TALMMY1001-PT3 (Annan identifierare: Janssen Research & Development, LLC)
  • 2017 (U.S.S. NIH-anslag/kontrakt)
  • 2023-504581-29-00 (Registeridentifierare: EUCT number)
  • 2023 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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